Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

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Area of Late Phase Skin Response [ Time Frame: Baseline and 14 weeks ]

Area of Early Phase Skin Response [ Time Frame: Baseline and 14 weeks ]

Change in CPT score [ Time Frame: Baseline and 4 weeks ]

Grass specific IgG4 [ Time Frame: Baseline and 14 weeks ]

Change in CPT score [ Time Frame: Baseline and 14 weeks ]

Area of Early Phase Skin Response [ Time Frame: Baseline and 17 weeks ]

Grass specific IgE [ Time Frame: Baseline and 17 weeks ]

Area of Late Phase Skin Response [ Time Frame: Baseline and 17 weeks ]

Change in CPT score [ Time Frame: 17 weeks after start of treatment ]

Change in CPT score [ Time Frame: Baseline and 8 weeks ]

Change in CPT score [ Time Frame: Baseline and 12 weeks ]

Grass specific IgE [ Time Frame: Baseline and 14 weeks ]

Original Secondary Outcome Measures ICMJE (submitted: July 19, 2010)

Area of Late Phase Skin Response [ Time Frame: 0 weeks after start of treatment ]

Area of Early Phase Skin Response [ Time Frame: 0 weeks after start of treatment ]

Change in CPT score [ Time Frame: 0 weeks after start of treatment ]

Grass specific IgE [ Time Frame: 0 weeks after start of treatment ]

Grass specific IgG4 [ Time Frame: 14 weeks after start of treatment ]

Area of Late Phase Skin Response [ Time Frame: 14 weeks after start of treatment ]

Area of Early Phase Skin Response [ Time Frame: 14 weeks after start of treatment ]

Change in CPT score [ Time Frame: 14 weeks after start of treatment ]

Area of Early Phase Skin Response [ Time Frame: 17 weeks after start of treatment ]

Grass specific IgE [ Time Frame: 17 weeks after start of treatment ]

Area of Late Phase Skin Response [ Time Frame: 17 weeks after start of treatment ]

Change in CPT score [ Time Frame: 17 weeks after start of treatment ]

Change in CPT score [ Time Frame: 4 weeks after start of treatment ]

Change in CPT score [ Time Frame: 8 weeks after start of treatment ]

Change in CPT score [ Time Frame: 12 weeks after start of treatment ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis

Official Title ICMJE

An Escalating, Multiple-dose Study in Grass Allergic Subjects to Assess the Safety of Intradermal Injection of ToleroMune Grass

Brief Summary

Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.

ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.

The purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of ToleroMune Grass in subjects allergic to grass.

Detailed Description

This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 6 weeks before randomisation.

Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The first cohort will receive the lowest dose and successive dose groups will increasing doses of ToleroMune Grass, provided the first administration of the previous dose was safe and well tolerated.

In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks after the last administration in the Treatment Period and the second will be 17 weeks after the first administration. Follow-up will be conducted 3-10 days after the second PTC.